Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the phase III randomized, double-blind ECHO and THRIVE trials

Journal of Antimicrobial Chemotherapy

Volumn 67, Issue 8, 2012, Pages 2020-2028

  Nelson, Mark ^a   Amaya, Gerardo ^b   Clumeck, Nathan ^c   Arns da cunha, Clovis ^d   Jayaweera, Dushyantha ^e   Junod, Patrice ^f   Li, Taisheng ^g   Tebas, Pablo ^h   Stevens, Marita ⁱ   Buelens, Annemie ⁱ   Vanveggel, Simon ⁱ   Boven, Katia ^j   Abusamra, L ^k   Cahn, P ^k   Laplume, H E ^k   Cassetti, I ^k   Ceriotto, M ^k   Martins, M D ^k   Krolewiecki, A ^k   Amarilis Lugo, L ^k   Bolan, R ^k   Bush, L ^k   Corales, R ^k   Crane, L ^k   De Vente, J ^k   Fischl, M ^k   Gathe, J ^k   Greenberg, R ^k   Henry, K ^k   Jayaweera, D ^k   Kumar, P ^k   Lalezari, J ^k   Leider, J ^k   Lubelchek, R ^k   Martorell, C ^k   Mounzer, K ^k   Cohen, C ^k   Olivet, H ^k   Ortiz, R ^k   Rhame, F ^k   Roberts, A ^k   Ruane, P ^k   Scribner, A ^k   Segal Maurer, S ^k   Short, W ^k   Sloan, L ^k   Wilkin, T ^k   Wohlfeiler, M ^k   Yangco, B ^k   Bloch, M ^k   Gold, J ^k   Hoy, J ^k   Martinez, P ^k   Baker, D ^k   Finlayson, R ^k   Roth, N ^k   Rieger, A ^k   Vetter, N ^k   Zangerle, R ^k   Da Cunha, C A ^k   Grinsztejn, B ^k   Madruga, J V ^k   Pilotto, J H ^k   Sampaio, D ^k   Gonsalez, C R ^k   Lima, M P ^k   Rangel, F ^k   Timerman, A ^k   Junod, P ^k   Kilby, D ^k   Rachlis, A ^k   Walmsley, S ^k   Boissonnault, M ^k   Brunetta, J ^k   De Wet, J ^k   Gill, J ^k   Kasper, K ^k   Macleod, J ^k   Gerstoft, J ^k   Mathiesen, L ^k   Pedersen, C ^k   Cotte, L ^k   Girard, P M ^k   Molina, J M ^k   Raffi, F ^k   Vittecoq, D ^k   Yazdanpanah, Y ^k   Yeni, P ^k   Boue, F ^k   Katlama, C ^k   Reynes, J ^k   Fisher, M ^k   Nelson, M ^k   Orkin, C ^k   Taylor, S ^k   Johnson, M ^k   Wilkins, E ^k   Williams, I G ^k   Winston, A ^k   Lazzarin, A ^k   Narciso, P ^k   Orani, A ^k   Rusconi, S ^k   Antinori, A ^k   Carosi, G ^k   Mazzotta, F ^k   Amaya, G ^k   Reyes Teran, G ^k   Andrade Villanueva, J ^k   Sierra Madero, J G ^k   Rijnders, B ^k   Santana, J ^k   Zorrilla, C ^k   Antunes, F ^k   Branco, T ^k   Sarmento, R ^k   Castro, E ^k   Eugenio, T ^k   Mansinho, K ^k   Marques, R ^k   Duiculescu, D ^k   Negrutiu, L ^k   Prisacariu, L ^k   Kulagin, V ^k   Voronin, E ^k   Yakovlev, A ^k   Dushkina, N ^k   Pronin, A ^k   Tsibakova, O ^k   Vinogradova, E ^k   Baraldi, E ^k   David, N ^k   Ebrahim, O ^k   Krantz, E ^k   Latiff, G H ^k   Spencer, D ^k   Wood, R ^k   Botes, M ^k   Conradie, F ^k   Fourie, J ^k   Mohapi, L ^k   Petit, D ^k   Steyn, D ^k   Arribas, J R ^k   Portilla Sogorb, J ^k   Ribera, E ^k   Santos Gil, I ^k   Clotet, B ^k   Gutierrez, F ^k   Podzamczer, D ^k   Soriano, V ^k   Westling, K ^k   Chetchotisakd, P ^k   Sirisanthana, T ^k   Sungkanuparph, S ^k   Vibhagool, A ^k   Ruxrungtham, K ^k   Techasathit, W ^k   Hung, C C ^k   Lee, H C ^k   Lin, H H ^k   Wong, W W ^k   Albrecht, H ^k   Bellos, N ^k   Berger, D ^k   Brinson, C ^k   Casanas, B ^k   Elion, R ^k   Feinberg, J ^k   File, T ^k   Flamm, J ^k   Hicks, C ^k   Hodder, S ^k   Hsiao, C B ^k   Kadlecik, P ^k   Khanlou, H ^k   Kinder, C ^k   Liporace, R ^k   Mayer, C ^k   Mildvan, D ^k   Mills, A ^k   Myers, R A ^k   Nadeem, I ^k   Osiyemi, O ^k   Para, M ^k   Pierone, G ^k   Rashbaum, B ^k   Rodriguez, J ^k   Saag, M ^k   Sampson, J ^k   Samuel, R ^k   Sension, M ^k   Shalit, P ^k   Tebas, P ^k   Towner, W ^k   Wilkin, A ^k   Eron, J ^k   Wohl, D ^k   Colebunders, R ^k   Clumeck, N ^k   Goffard, J C ^k   Van Wanzeele, F ^k   Van Wijngaerden, E ^k   Ballesteros, J ^k   Northland, R ^k   Perez, C ^k   Hongzhou, L ^k   Li, T ^k   Cai, W ^k   Wu, H ^k   Li, X ^k   Herrera, G ^k   Arasteh K ^k   Esser, S ^k   Fatkenheuer G ^k   Lutz, T ^k   Schmidt, R ^k   Schuster, D ^k   Stellbrink, H J ^k   Kumarasamy, N ^k   Patil, P ^k   Canton Martinez, A ^k   Rodriguez French, A ^k   Sosa, N ^k   more..

^a CHELSEA AND WESTMINSTER HOSPITAL   (United Kingdom)

^b UNIVERSITY OF GUADALAJARA   (Mexico)

^c SAINT PIERRE UNIVERSITY HOSPITAL   (Belgium)

^d Centro Medico Sao Francisco   (Brazil)

^e UNIVERSITY OF MIAMI   (United States)

^f Clinique Medicale du Quartier Latin   (Canada)

^g PEKING UNION MEDICAL COLLEGE HOSPITAL   (China)

^h HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

ⁱ JANSSEN RESEARCH FOUNDATION   (Belgium)

^j JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^k NONE

more..

Author keywords

Efavirenz; HBV; HCV; Hepatic safety; Hepatitis; Non nucleoside reverse transcriptase inhibitors; TMC278

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; EFAVIRENZ; HEPATITIS B SURFACE ANTIGEN; HEPATITIS C ANTIBODY; RILPIVIRINE;

ACUTE HEPATITIS; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIVIRAL THERAPY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CHOLELITHIASIS; CONTROLLED STUDY; CYTOLYTIC HEPATITIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATTY LIVER; FEMALE; HEPATITIS; HEPATITIS B; HEPATITIS C; HEPATOMEGALY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HYPERBILIRUBINEMIA; HYPERTRANSAMINASEMIA; LIVER FUNCTION; LIVER FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MIXED INFECTION; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; SIDE EFFECT; THERAPY EFFECT; TREATMENT RESPONSE; VIRUS LOAD;

ADOLESCENT; ADULT; AGED; ALANINE TRANSAMINASE; ANIMALS; ANTIVIRAL AGENTS; ASPARTATE AMINOTRANSFERASES; BENZOXAZINES; COINFECTION; DOUBLE-BLIND METHOD; DRUG TOXICITY; FEMALE; HEPATITIS B; HEPATITIS B SURFACE ANTIGENS; HEPATITIS C; HEPATITIS C ANTIBODIES; HIV INFECTIONS; HIV-1; HUMANS; LIVER; LIVER FUNCTION TESTS; MALE; MIDDLE AGED; NITRILES; PLACEBOS; PYRIMIDINES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84864505008     PISSN: 03057453     EISSN: 14602091     Source Type: Journal    
DOI: 10.1093/jac/dks130     Document Type: Article

References (47)

1. Alter MJ. Epidemiology of viral hepatitis and HIV co-infection. J Hepatol 2006; 44 Suppl: S6-9.
2. Konopnicki D, Mocroft A, de Wit S et al. Hepatitis B and HIV: prevalence, AIDS progression, response to highly active antiretroviral therapy and increased mortality in the EuroSIDA cohort. AIDS 2005; 19: 593-601.
3. Thio CL, Seaberg EC, Skolasky R Jr et al. HIV-1, hepatitis B virus, and risk of liver-related mortality in the Multicenter Cohort Study (MACS). Lancet 2002; 360: 1921-6.
4. Sulkowski MS. Management of hepatic complications in HIV-infected persons. J Infect Dis 2008; 197 Suppl 3: S279-93.
5. Thein HH, Yi Q, Dore GJ et al. Natural history of hepatitis C virus infection in HIV-infected individuals and the impact of HIV in the era of highly active antiretroviral therapy: a meta-analysis. AIDS 2008; 22: 1979-91.
6. Matthews GV, Avihingsanon A, Lewin SR et al. A randomized trial of combination hepatitis B therapy in HIV/HBV coinfected antiretroviral naive individuals in Thailand. Hepatology 2008; 48: 1062-9.
7. Peters MG, Andersen J, Lynch P et al. Randomized controlled study of tenofovir and adefovir in chronic hepatitis B virus and HIV infection: ACTG A5127. Hepatology 2006; 44: 1110-6.
8. Puoti M, Cozzi-Lepri A, Paraninfo G et al. Impact of lamivudine on the risk of liver-related death in 2,041 HBsAg- and HIV-positive individuals: results from an inter-cohort analysis. Antivir Ther 2006; 11: 567-74.
9. Avidan NU, Goldstein D, Rozenberg L et al. Hepatitis C viral kinetics during treatment with peg IFN-a-2b in HIV/HCV coinfected patients as a function of baseline CD4+ T-cell counts. J Acquir Immune Defic Syndr 2009; 52: 452-8.
10. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Department of Health and Human Services, 10 January 2011; 1-174. http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf (21 September 2011, date last accessed).
11. WHO. Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a Public Health Approach - 2010 Revision. http://whqlibdoc.who.int/publications/2010/9789241599764_eng.pdf (21 September 2011, date last accessed).
12. Thompson MA, Aberg JA, Cahn P et al. Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society-USA panel. JAMA 2010; 304: 321-33.
13. Aceti A, Pasquazzi C, Zechini B et al. Hepatotoxicity development during antiretroviral therapy containing protease inhibitors in patients with HIV: the role of hepatitis B and C virus infection. J Acquir Immune Defic Syndr 2002; 29: 41-8.
14. Bonfanti P, Landonio S, Ricci E et al. Risk factors for hepatotoxicity in patients treated with highly active antiretroviral therapy. J Acquir Immune Defic Syndr 2001; 27: 316-8.
15. den Brinker M, Wit FW,Wertheim-van Dillen PM et al. Hepatitis B and C virus co-infection and the risk for hepatotoxicity of highly active antiretroviral therapy in HIV-1 infection. AIDS 2000; 14: 2895-902.
16. Núñez M, Lana R, Mendoza JL et al. Risk factors for severe hepatic injury after introduction of highly active antiretroviral therapy. J Acquir Immune Defic Syndr 2001; 27: 426-31.
17. Saves M, Raffi F, Clevenbergh P et al. Hepatitis B or hepatitis C virus infection is a risk factor for severe hepatic cytolysis after initiation of a protease inhibitor-containing antiretroviral regimen in human immunodeficiency virus-infected patients. The APROCO Study Group. Antimicrob Agents Chemother 2000; 44: 3451-5.
18. Sulkowski MS, Thomas DL, Chaisson RE et al. Hepatotoxicity associated with antiretroviral therapy in adults infected with human immunodeficiency virus and the role of hepatitis C or B virus infection. JAMA 2000; 283: 74-80.
19. Wit FW, Weverling GJ, Weel J et al. Incidence of and risk factors for severe hepatotoxicity associated with antiretroviral combination therapy. J Infect Dis 2002; 186: 23-31.
20. Fuping G,Wei L, Yang H et al. Impact of hepatitis C virus coinfection on HAART in HIV-infected individuals: multicentric observation cohort. J AIDS 2010; 54: 137-42.
21. Dieterich DT, Robinson PA, Love J et al. Drug-induced liver injury associated with the use of nonnucleoside reverse-transcriptase inhibitors. Clin Infect Dis 2004; 38 Suppl 2: S80-9.
22. Lucas GM, Chaisson RE, Moore RD. Comparison of initial combination antiretroviral therapy with a single protease inhibitor, ritonavir and saquinavir, or efavirenz. AIDS 2001; 15: 1679-86.
23. Martinez E, Blanco JL, Arnaiz JA et al. Hepatotoxicity in HIV-1-infected patients receiving nevirapine-containing antiretroviral therapy. AIDS 2001; 15: 1261-8.
24. Moyle G. The emerging roles of non-nucleoside reverse transcriptase inhibitors in antiretroviral therapy. Drugs 2001; 61: 19-26.
25. Peters PJ, Stringer J, McConnell MS et al. Nevirapine-associated hepatotoxicity was not predicted by CD4 count ≥250 cells/mL among women in Zambia, Thailand and Kenya. HIV Med 2010; 11: 650-60.
26. DeJesus E, Herrera G, Teofilo E et al. Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults. Clin Infect Dis 2004; 39: 1038-46.
27. Gallant JE, Staszewski S, Pozniak AL et al. Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial. JAMA 2004; 292: 191-201.
28. Gallant JE, DeJesus E, Arribas JR et al. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med 2006; 354: 251-60.
29. Manfredi R, Calza L, Chiodo F. Efavirenz versus nevirapine in current clinical practice: a prospective, open-label observational study. J Acquir Immune Defic Syndr 2004; 35: 492-502.
30. Martin-Carbonero L, Núñez M, Gonzalez-Lahoz J et al. Incidence of liver injury after beginning antiretroviral therapy with efavirenz or nevirapine. HIV Clin Trials 2003; 4: 115-20.
31. Martinez E, Arnaiz JA, Podzamczer D et al. Substitution of nevirapine, efavirenz, or abacavir for protease inhibitors in patients with human immunodeficiency virus infection. N Engl J Med 2003; 349: 1036-46.
32. Sulkowski MS, Thomas DL, Mehta SH et al. Hepatotoxicity associated with nevirapine or efavirenz-containing antiretroviral therapy: role of hepatitis C and B infections. Hepatology 2002; 35: 182-9.
33. van Leth F, Phanuphak P, Ruxrungtham K et al. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study. Lancet 2004; 363: 1253-63.
34. Law WP, Dore GJ, Duncombe CJ et al. Risk of severe hepatotoxicity associated with antiretroviral therapy in the HIV-NAT cohort, Thailand, 1996-2001. AIDS 2003; 17: 2191-9.
35. Boehringer Ingelheim Pharmaceuticals, Inc. Viramunew (Nevirapine) Prescribing Information - January 2011. http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Viramune/Viramune.pdf (21 September 2011, date last accessed).
36. Janssen-Cilag International NV. EDURANT 25 mg Film-Coated Tablets, Summary of Product Characteristics, 2011. http://www.medicines.org.uk/ EMC/medicine/25490/SPC/Edurant+25+mg/ (4 April 2012, date last accessed).
37. Janssen, Inc. EDURANTTM (Rilpivirine) Tablets, Full Prescribing Information, 2011. http://www.edurant-info.com/sites/default/files/EDURANT-PI.pdf (4 April 2012, date last accessed).
38. Janssen, Inc. EDURANTTM (Rilpivirine) Tablets, Product Monograph, Canada, 2011. http://webprod3.hc-sc.gc.ca/dpd-bdpp/item-iteme.do?pmmp=00013725 (4 April 2012, date last accessed).
39. Cohen C, Molina J-M, Cahn P et al. Efficacy and safety of rilpivirine (TMC278) versus efavirenz at 48 weeks in treatment-naïve, HIV-1-infected patients: pooled results from the phase 3 double-blind, randomized ECHO and THRIVE trials. J Acquir Immune Defic Syndr 2012; 60: 33-42.
40. Núñez M. Hepatotoxicity of antiretrovirals: incidence, mechanisms and management. J Hepatol 2006; 44 Suppl: S132-9.
41. Molina J-M, Cahn P, Grinsztejn B et al. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet 2011; 378: 238-46.
42. Cohen CJ, Andrade-Villanueva J, Clotet B et al. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet 2011; 378: 229-37.
43. Vingerhoets J, Rimsky L, Van Eygen V et al. Screening and baseline mutations in the TMC278 phase III trials ECHO and THRIVE: prevalence and impact on virological response (Abstract 41). Antivir Ther 2011; 16 Suppl 1: A51.
44. AIDS Clinical Trials Group. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December 2004. Clarification August 2009. http://rsc.tech-res.com/safetyandpharmacovigilance/ (21 September 2011, date last accessed).
45. Medical Dictionary for Regulatory Activities (MedDRA) Version 11.0. http://meddramsso.com (21 September 2011, date last accessed).
46. Kontorinis N, Dieterich D. Hepatotoxicity of antiretroviral therapy. AIDS Rev 2003; 5: 36-43.
47. Bruck S, Witte S, Brust J et al. Hepatotoxicity in patients prescribed efavirenz or nevirapine. Eur J Med Res 2008; 13: 343-8.